Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT04701112 |
| Other study ID # |
Hepa-His trial |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
February 28, 2026 |
Study information
| Verified date |
November 2023 |
| Source |
Region Skane |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) is indicated for
patients with low ejection fraction and persistent symptoms of heart failure despite medical
therapy and a wide QRS-complex, preferably with a left bundle branch block. Unfortunately, up
to 40 % receiving CRT do not respond with subjective improvement or improved left ventricular
ejection fraction from the treatment.
There are few therapeutic alternatives in patients not responding to CRT with BVP, and the
potential to improve cardiac function in these patients could make a large difference in
terms of life quality and prognosis.
His-bundle pacing (HBP) can be a suitable alternative, but is likely not possible in all
patients with failed CRT. Furthermore, upgrading to HBP does require a surgical procedure and
therefore exposes the patients to risk of complications (e.g. infection of the device).
Therefore, early identification of the patients who are likely to benefit from an upgrade to
HBP would be beneficial.
This study aims to evaluate if patients with failed CRT treatment will benefit from
hemodynamic improvement if they are treated with temporary HBP, without opening the
device-pocket, and exposing the existing pacemaker-device to a risk of infection. A temporary
pacemaker lead and pacing sheath will be used, and placed in the heart via a blood vessel on
the right side of neck, using local anaesthesia. Acute effects on the pump function of the
heart will be measured during rest and during supine bicycle test (the equivalent of moderate
physical activity). Factors associated with a beneficial effect will be evaluated on a group
basis.
If the individual patient experiences an improvement of cardiac function during the test,
he/she will be offered an upgrade to HBP and a replacement of the existing device.
Description:
Primary hypothesis:
His-bundle pacing will lead to a better stroke volume at rest compared to biventricular
pacing.
Primary outcome measure:
Stroke-volume (ml) at rest assessed by invasive hemodynamic measurements with the
thermodilution method using a Swan-Ganz catheter.
Recruitment:
Patients will be recruited from the dedicated CRT outpatient clinic at Skane University
Hospital. This outpatient clinic evaluates all CRT recipients at 6 months after device
implant. If the patient is then a "non-responder" by subjective and objective measures, it is
unlikely that there will be any further benefit from the CRT device. Those patients
fulfilling the inclusion criteria but not the exclusion criteria will therefore be invited to
participate in the study. Written information will be provided to all patients prior to
informed consent is signed.
Procedure:
All patients will undergo a temporary His-bundle stimulation and hemodynamic evaluation. The
procedure takes place at the dedicated laboratory for advanced hemodynamic evaluation at
Skåne University Hospital in Lund. The first option for vascular access is the right external
jugular vein. Under sterile conditions, ultrasound guided venous puncture will be performed,
using standard Seldinger technique. A 7F catheter (Medtronic C315) will then be placed over a
long guidewire, and used to direct a dedicated pacemaker lead (Medtronic Select Secure 3830)
to the His bundle. In case of technical difficulties, a steerable 9F catheter will be used
instead (Medtronic C304 deflectable). If HBP is not possible using jugular access, an
alternate access via the right femoral vein may be used instead. If the femoral vein is used,
only resting measurements will be performed, since it is not possible to thread on the supine
bike with a catheter in situ via the femoral vein. In parallel, in a short 8F introducer, a
7F multilumen Swan Ganz catheter will be placed over a long guidewire, and advanced to the
left or right pulmonary artery. The catheter will then be wedged in a pulmonary segmental
artery to obtain left atrial pressure curves.
The pacing lead will be connected to an electrophysiology 12-lead ECG system with capability
of pacing and continuous ECG registration of external and intracardiac signals. His bundle
potential will be identified probing the correct anatomical area with the electrode, and
subsequently the pacing properties of the electrode will be tested. If the pacing properties
result in selective (or subsidiary non-selective) his bundle capture, the electrode will be
secured in place by 2-3 careful rotations of the entire electrode. The goal is to achieve a
stable position with minimal risk of damaging the conduction system by trauma. Since the
patients are paced using the CRT device anyway, trauma to the conduction system will not be
deleterious, but it may hamper the ability to place a permanent HBP lead at a later stage, if
that is indicated. When stable pacing conditions are in place, the stimulation program will
be initiated. Depending on randomization results, the intrinsic CRT system or the temporary
His-lead will be used for pacing. Pacing and sensing in the right atrium will be achieved
using atrial electrodes on the outside of the Swan Ganz catheter.
The patients are randomized to wither Biventricular pacing first or HBP first. The pacing
program involves both pacing at rest and pacing during sub maximal exercise test (supine
bicycle test). Each pacing step is sustained at steady state for at least 2 minutes prior to
measurement of intracardiac pressures, cardiac output and stroke volume calculations. After
the pacing protocol is finished, the catheters are withdrawn and the site of venopuncture is
manually compressed during 5 minutes. The patients are then observed during 2 hours, before
discharge and completion of the study.
A hemodynamic optimization will be performed regarding device settings for all patients.
Patients who have a positive hemodynamic response to HBP, compared to CRT pacing, will at a
follow-up stage be offered an upgrade to permanent HBP.
